GI Genius is an AI-enabled medical device from Cosmo Artificial Intelligence - AI Ltd, listed by FDA (510(k), K211951) with a decision date of 2021-07-23. Review panel: Gastroenterology-Urology.
| FDA submission number | K211951 |
|---|---|
| Pathway | 510(k) |
| Company | Cosmo Artificial Intelligence - AI Ltd |
| Review panel (specialty) | Gastroenterology-Urology |
| FDA decision date | 2021-07-23 |
| Decision | Substantially Equivalent |
| Product code | QNP |
| Classification | Gastrointesinal Lesion Software Detection System |
| Device class | 2 |
| Regulation number | 876.1520 |
| Review time (calendar days) | 30 |
| Applicant country | IE |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.